CataractNCT00758576

ReSTOR Natural +3.0D Study In Japan

A study testing ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 in people with Cataract, run by Alcon Research at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cataract
What is being tested?: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteJapan
Study dates: Feb 2008to Dec 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned bilateral cataract removal by phacoemulsification
Potential postoperative best corrected visual acuity of 0.5 or over
1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Who cannot join

Poorly controlled glaucoma
Progressive diabetic retinopathy

Trial locations and contacts

1 site in 1 country.

Japan1 site

Hayashi Eye Hospital
Fukuoka, Fukuoka, 812-0011

Other trials in Japan

About this study

Official title: ReSTOR Natural +3.0D (Diopter) Study In Japan

Conditions: Cataract
Being tested: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Keywords: Cataract
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1Device
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Study groups in NCT00758576
Study group	Role	What they receive
SN6AD1	Experimental	AcrySof ReSTOR Model SN6AD1 Intraocular Lens Receives: Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

What is being measured

The primary outcome is the main question the study is designed to answer.

Uncorrected Intermediate Visual Acuity
Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Measured: 1 year after surgery
Uncorrected Distance Visual Acuity
Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Measured: 1 year after surgery
Uncorrected Near Visual Acuity
Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Measured: 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Dec 2009

First posted25 Sep 2008 (estimated)
Study startFeb 2008
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758576
Sponsor's protocol ID: C-07-44
Status last verified: Dec 2010
First submitted: 23 Sep 2008
Last updated: 21 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ReSTOR Natural +3.0D (Diopter) Study In Japan
ClinicalTrials.gov ID: NCT00758576
Acronym / sponsor ID: C-07-44
Conditions: Cataract
Keywords: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 2 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SN6AD1	Experimental	Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1AcrySof ReSTOR Model SN6AD1 Intraocular Lens

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Planned bilateral cataract removal by phacoemulsification
Potential postoperative best corrected visual acuity of 0.5 or over
1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Key exclusion criteria (2 listed)

Poorly controlled glaucoma
Progressive diabetic retinopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.	Device	SN6AD1

Primary outcome

Uncorrected Intermediate Visual Acuity
Time frame: 1 year after surgery
Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Distance Visual Acuity
Time frame: 1 year after surgery
Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Near Visual Acuity
Time frame: 1 year after surgery
Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Results and safety

Results posted to the registry on 2 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SN6AD1	64	63

Primary outcome: Uncorrected Intermediate Visual Acuity

Time frame: 1 year after surgery. Mean (Full Range). Unit: Decimal Visual Acuity

Measure	SN6AD1 n = 63
1 meter	0.771 (0.3 to 1.2)
50 centimeters	0.861 (0.5 to 1.2)

Population analysed: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Primary outcome: Uncorrected Distance Visual Acuity

Time frame: 1 year after surgery. Mean (Full Range). Unit: Decimal Visual Acuity

Measure	SN6AD1 n = 63
Value	1.122 (0.4 to 2.0)

Population analysed: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Primary outcome: Uncorrected Near Visual Acuity

Time frame: 1 year after surgery. Mean (Full Range). Unit: Decimal Visual Acuity

Measure	SN6AD1 n = 63
Value	1.082 (0.6 to 1.9)

Population analysed: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Adverse events

Time frame: From time of surgery to 1 year following surgery.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SN6AD1	1 of 64 (1.6%)	0 of 64 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
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Active, not recruitingObservational study
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Age-Related Macular Degeneration, Cataract
RecruitingObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 in people with Cataract, run by Alcon Research at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected Intermediate Visual Acuity (time frame: 1 year after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00758576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2010.